An overview of the drug approval process

Research Initiative/Treatment Action!, Summer, 2002 by L. Joel Martinez

Drug classification. Finally, another way the FDA has attempted to streamline the review process is by adopting the practice of classifying drugs under consideration as "Standard" or "Priority." Standard drugs are those that provide only minor or no improvement in therapeutics, whereas Priority drugs are those that have the potential to provide a major advance in care. The review of Priority drugs is accelerated and the FDA will mobilize available personnel to review the large amount of technical information contained in an NDA of a Priority drug.

In the case of AIDS therapies, the FDA has created an "AA" priority category to ensure that these drugs receive the highest priority in the review process. Additionally, in 1988 the FDA issued interim regulations that allowed expedited marketing approval of new drugs directly from phase 2, when sponsors had early consultation with the FDA and designed phase 2 clinical trials that provided sufficient data to prove efficacy and support approval.

Consequences of streamlining the system. The expedited methods devised to accelerate access to HIV/AIDS drugs have served to provide investigational drugs to many patients who might have otherwise died from the disease. However, there has been some concern that in the haste to provide access and approval of new therapies, the scientific and medical communities have not learned the best ways to use these drugs. Drugs approved on the basis of surrogate markers are often used without the benefit of knowing the long-term clinical consequence of their use. For this reason many advocates have determined that it may be time to require sponsors to conduct more long-term clinical endpoint studies that would give patients a better idea of how to use these drugs for the long haul.

Antiretrovirals Currently Approved for HIV Infection

ANTIRETROVIRALS                   Submission   Approval   Approximate
Brand name (generic name/         Date of NDA  Date       Approval Time
original manufacturer)

Retrovir capsules (zidovudine,
  AZT / Glaxo Wellcome)           02 DEC 86    19 MAR 87  3.5 months
Retrovir syrup                    28 OCT 88    28 SEP 89  11 months
Retrovir injection                01 FEB 89    02 FEB 90  12 months
Videx (didanosine, ddI /
  Bristol-Myers Squibb)           06 APR 01    09 OCT 91  6 months
Hivid (zalcitabine, ddC /
  Hoffmann-La Roche)              31 OCT 01    19 JUN 92  8.5 months
Zerit (stavudine, d4T /
  Bristol-Myers Squibb            28 DEC 93    24 JUN 94  6 months
Epivir (lamivudine, 3TC /
  Glaxo Wellcome)                 30 JUN 05    17 NOV 95  4.5 months
Invirase (saquinavir /
  Hoffmann-La Roche)              08 AUG 95    06 DEC 95  3 months
Norvir (ritonavir / Abbott
  Laboratories)                   21 DEC 95    01 MAR 96  2.5 months
Crixivan (indinavir / Merck &
  Co., Inc)                       31 JAN 96    13 MAR 96  1.5 months
Viramune (nevirapine/Boehringer
  Ingelheim Pharmaceuticals,
  Inc)                            23 FEB 96    21 JUN 96  4 months
Viracept (nelfinavir / Agouron
  Pharmaceuticals)                26 DEC 96    14 MAR 97  3 months
Rescriptor (delavirdine /
  Pharmacia & Upjohn)             15 JUL 96    04 APR 97  9 months
Combivir (zidovudine and
  lamivudine / Glaxo Wellcome)    30 MAY 97    26 SEP 97  4 months
Fortovase (saquinavir, soft
  gelatin capsule / Hoffmann-La
  Roche                           12 MAY 97    07 NOV 97  6 months
Sustiva (efavirenz / DuPont
  Pharmaceuticals)                11 JUN 98    17 SEP 98  3 months
Ziagen (abacavir / Glaxo
  Wellcome)                       24 JUN 98    17 DEC 98  6 months
Agenerase (amprenavir / Glaxo
  Wellcome)                       16 OCT 98    15 APR 99  6 months
Norvir (ritonavir, soft gelatin
  capsule / Abbott Laboratories)  02 MAR 09    29 JUN 99  3 months
Kaletra (lopinavir, ritonavir /
  Abbott Laboratories)            01 JUN 00    15 SEP 00  3 months
Videx EC (enteric-coated
  didanosine / Bristol-Myers
  Squibb)                         31 JAN 00    31 OCT 00  9 months
Trizivir (abacavir, zidovudine,
  lamivudine / Glaxo Wellcome)    17 DEC 99    14 NOV 00  12 months
Viread (tenofovir disoproxil
  fumarate / Gilead Sciences,
  Inc)                            01 MAY 01    96 OCT 01  5.5 months